Product Dossier
ADRENALINE-LINK
Product Dossier for ADRENALINE-LINK (adrenaline (epinephrine) acid tartrate, Link Pharmaceuticals). ARTG record, PBS listing, PBAC outcomes — compiled by…
- Sponsor: Link Pharmaceuticals
- Active ingredient: adrenaline (epinephrine) acid tartrate
- Therapeutic area: Cardiology
- Related brand: Marcain
- Related brand: DELTAZINE
- Related brand: MARCAIN
- Same area: ATOZET
- Same area: OPSUMIT
What it is
Adrenaline-Link is adrenaline (epinephrine) acid tartrate supplied as pre-filled auto-injector pens in two strengths: Jext Jnr 150, which delivers a single dose of 150 micrograms, and Jext 300, which delivers a single dose of 300 micrograms. The product is a solution for injection in a pre-filled cartridge based auto-injector. The formulation contains sulfites.
Approved indications
— Emergency treatment of anaphylaxis (acute severe allergic reactions) due to insect stings, or bites, foods, drugs or other allergens.
Dosing overview
Patients weighing between 15 kg and 30 kg should receive 150 micrograms. Children and adolescents weighing over 30 kg and adults should be prescribed the 300 microgram dose. If there is no clinical improvement or if deterioration occurs, a second injection may be administered 5–15 minutes after the first injection. It is recommended that patients are prescribed two Adrenaline-Link pens which they should carry at all times. Adrenaline-Link is administered by intramuscular injection into the anterolateral thigh. The product is designed to inject through clothing or directly through the skin.
Key safety warnings
Adrenaline-Link should not be injected intravenously as cerebral haemorrhage may occur due to a sharp rise in blood pressure. Patients should be advised not to inject Adrenaline-Link into the gluteus maximus due to the risk of accidental injection into a vein. Due to an increased risk of adverse reactions following administration of adrenaline, special caution should be taken in patients with cardiovascular diseases including angina pectoris, obstructive cardiomyopathy, cardiac arrhythmia, cor pulmonale, atherosclerosis and hypertension. Adrenaline can cause potentially fatal ventricular arrhythmias including fibrillation, especially in patients with organic heart disease or those receiving other drugs that sensitise the heart to arrhythmias. Rare cases of serious skin and soft tissue infections, including necrotising fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported at the injection site. Clostridium spores can be present on the skin and introduced into deep tissue with injection. While alcohol cleansing may reduce presence of bacteria on the skin, it does not kill Clostridium spores. To decrease the risk of Clostridium infection, do not inject Adrenaline-Link into the buttock. Adrenaline-Link contains sodium metabisulfite which may rarely cause severe hypersensitivity reactions including anaphylactic symptoms and bronchospasm in susceptible people, especially those with a history of asthma. Patients taking non-selective beta-blocking drugs may experience severe hypertension and bradycardia when administered adrenaline for anaphylaxis. The cardiostimulating and bronchodilating effects of adrenaline are antagonised by beta-adrenergic blocking drugs.
Contraindications
There are no absolute contraindications to the use of Adrenaline-Link during an allergic emergency.
Regulatory history
Adrenaline-Link was first registered on the ARTG in 1991 as a 1:1,000 adrenaline injection in ampoule form. A 1:10,000 ampoule formulation was added to the register in 2005. A pre-filled syringe variant was registered in 2013.